Kornimate/medical-research-clean huggingface dataset:
ipack for post-op pain following acl reconstruction

Conditions: ACL Injury; Post Operative Pain

Summary: this study will consist of patients 12 years and older undergoing acl reconstruction using a quadriceps or bone-patella tendon bone (btb) graft. the patients will be randomized to adductor canal block alone, or adductor canal block + ipack block. the primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.


Eligibility criteria:
inclusion criteria: * age 12 years and older * patients who are scheduled to undergo an acl reconstruction with quadriceps or btb graft. exclusion criteria: * any contraindication to receiving regional anesthesia. this may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury. * patients undergoing hamstring graft or allograft for acl * pre-existing infection at the site of injury * patients on chronic opioid treatments * pre-existing sensory or motor deficit in operative extremity * patients having a revision of previous acl reconstruction * pregnant and/or lactating women * weighs less than 40kg

Keywords: acl injury acl repair
clinical characteristics of coronavirus disease 2019 (covid-19) in pregnancy: the italian registry on coronavirus in pregnancy.

Conditions: Infection Viral

Summary: the novel coronavirus (2019-ncov), also known as wuhan coronavirus, causes the 2019-ncov acute respiratory disease. the number of patients infected by 2019-ncov in italy closely followed an exponential trend, and italy reported the highest number of infected patients and deaths in the world excluding china.

coronaviruses (covs) are the largest group of viruses belonging to the nidovirales order. they are enveloped, non-segmented positive-sense rna viruses.1 coronavirus are believed to cause a significant proportion of all common colds in adults and children. the novel coronavirus (2019-ncov), also known as wuhan coronavirus, causes the 2019-ncov acute respiratory disease. the initial cases of 2019-ncov occurred in wuahn, china in december 2019.2 a recent review evaluated the potential impact of 2019-ncov in pregnancy.3 the authors reported published data on covs in pregnant women, including 2019-ncov, severe acute respiratory syndrome (sars-cov) and middle east respiratory syndrome (mers-cov). the review included 12 women with sars-cov,4 11 women mers-cov,5 and 9 women with 2019-n-cov6 in pregnancy. no cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (icu) (63.3%), and maternal death (18.8%). the number of patients infected in italy closely followed an exponential trend, and italy reported the highest number of infected patients and deaths in the world excluding china.7 therefore, italy can be a great source of data, including data on pregnant women. the aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-cov. this was a multicenter, retrospective, cohort study. clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-cov data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. all medical recors were sent to the coordinator center at university of naples federico ii. data were entered into a computerized database and cross-checked. if the core data were missing, requests for clarification were sent to the coordinators.

Eligibility criteria:
inclusion criteria: * pregnant women with laboratory-confirmed 2019-n-cov
dry eye screening and referral system

Conditions: Dry Eye

Summary: dry eye is one of the most common ocular surface diseases. its pathogenic factors are related to multiple etiology. because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists. the purpose of this study is to establish a case-control cohort of dry eye patients. multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (osdi), anterior segment photography, and treatment outcome of dry eye patients. the correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. the purpose of this study was to develop an artificial intelligence dry eye screening and referral system.


Eligibility criteria:
inclusion criteria: 1. subjects whose age are greater than or equal to 18 years old; 2. subjects who can cooperate with the inspection; 3. subjects who agree to participate in the study and sign the consent form. exclusion criteria: 1. subjects who cannot do the inspection. 2. subjects who suffer from diseases that compromise the inspection.
comparing perclose to statseal with perclose in transcatheter aortic valve replacement arteriotomy closure

Conditions: Arterial Occlusion; Cardiovascular Diseases; Hematoma

Summary: the purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. both devices are approved by the fda for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. it is believed that the use of both devices in combination compared to the perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.


Eligibility criteria:
inclusion criteria: delivery of a 14-16 french transcatheter aortic valve replacement system exclusion criteria: * use of a hemostasis method or device besides perclosetm (perclose may not be used in situations of heavy calcification, presence of dissection, etc). * use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure. * any use of glycoprotein inhibitors or cangrelor. * use of sheathless guides. * any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion. * any active treatment with oral anticoagulants continued during course of procedure. * presence of arteriovenous dialysis fistula in the ipsilateral leg. * any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band. * inability of the patient to personally consent for the study. (no surrogate consent) * cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
an investigational immuno-therapy study to determine the safety and effectiveness of nivolumab and daratumumab in patients with multiple myeloma

Conditions: Non-Hodgkin's Lymphoma; Hodgkin Lymphoma; Multiple Myeloma

Summary: the purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

note: currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * have received at least 3 prior lines of therapy, including a proteasome inhibitor \[pi\] and an immunomodulatory agent \[imid\] or have disease that is double refractory to a pi and imid * more than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant) * have detectable disease measured by a specific protein in your blood and/or urine * must consent to bone marrow aspirate or biopsy. exclusion criteria: * solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (mgus), smoldering multiple myeloma (smm), primary amyloidosis, waldenstrom's macroglobulinemia, poems syndrome or active plasma cell leukemia * prior therapy with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, anti ctla 4, or anti-cd38 antibody, or allogeneic stem cell transplantation * seropositive for human immunodeficiency virus (hiv), hepatitis b surface antigen or hepatitis c antibody positive (except if hcv-rna negative), or history of active chronic hepatitis b or c * history of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma other protocol defined inclusion/exclusion criteria could apply
effects of hfot on exercise performance in patients with copd. a randomized, controlled trial.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (hfot) vs. low-flow oxygen therapy (lfot) on cycling endurance in patients with chronic obstructive pulmonary disease (copd).

this will be a randomized, cross-over trial evaluating the efficacy of nasal hfot vs. lfot on cycling endurance in patients with copd. each patient will perform two constant load cycling exercise tests to exhaustion using hfot and lfot on two consecutive days, respectively, according to randomization. the load of the cycle ergometer will be set at 75% of the individually estimated maximum work rate (wmax). during exercise tests, lfot will be provided by a standard nasal cannula at a flow rate of 3 l/min using an oxygen concentrator. hfot will be applied by a dedicated large bore nasal cannula at a flow rate 60 l/min, fio2 45%, temperature 32 °c, using a hfot device.

Eligibility criteria:
inclusion criteria: men and women, 35 to 75 years of age, with moderate to severe copd, (fev1/fvc \<0.7, fev1 40-80% predicted, resting spo2 ≥92%, paco2 \<6 kpa at 760 m) who live \<800 m will be invited. exclusion criteria: copd exacerbation, very severe copd with hypoxemia (fev1/fvc \ 20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.

Keywords: exercise endurance high-flow oxygen therapy low-flow oxygen therapy
coping after pediatric scoliosis surgery

Conditions: Adolescent Idiopathic Scoliosis

Summary: this is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. the intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. the study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.


Eligibility criteria:
inclusion criteria: - all children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach exclusion criteria: * non-english speaking * non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic. * other comorbidity, including developmental delay. * any surgical complication that results in significant divergence from our institution's standard scoliosis pathway. * unplanned admission within 6 weeks of index operation. * active treatment psychotherapy and/or cognitive behavioral therapy for any reason

Keywords: pain function pediatric scoliosis scoliosis surgery spinal fusion idiopathic scoliosis coping coping skills education video intervention randomized prospective satisfaction adolescent opioid
clinical utility and safety of human umbilical cord mesenchymal stem cell secretome in moderate neurocognitive impairment (dementia)

Conditions: Dementia; Moderate Dementia

Summary: the goal of this clinical trial if to learn if human umbilical cord mesenchymal stem cell (hucmsc) derived secretome injection is safe and effective in patient with moderate dementia. the main questions it aims to answer are: 1. is hucmsc derived secretome safe to be use as a therapy in patients with moderate dementia? 2. how does hucmsc derived secretome affect pro inflammatory and anti inflammatory cytokine (il-6 and tnf alfa) in patient with moderate dementia? 3. what is the relationship between hucmsc derived secretome therapy with mini mental state examination? researchers will compare the intervention group (patients who are injected with hucmsc derived secretome) and control group (patients who are only monitored) participants will * be injected with hucmsc derived secretome or vitamin b12 every two weeks for 4 months * follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination


Eligibility criteria:
inclusion criteria: 1. age \&gt; 60 years old 2. patient diagnosed with dementia confirmed by psychiatrist or neurologist based on dsm-4 or icd 10 3. patient with mini-mental state examination (mmse) between 10 to 20 indicating moderate cognitive impairment 4. patient is in stable condition without life threatening disease or uncontrolled medical condition 5. patient undergoing stable dose treatment for other medical condition at least 4 months before the trial 6. patient with care giver or supporting family who can assist patient with research protocol exclusion criteria: 1. patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse 2. patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection 3. patient with severe psychiatry disorder such as schizophrenia and bipolar disorder 4. patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial 5. patient who has allergy or hypersensitivity reaction towards secretome 6. patient with medical complications or surgery complications that require immediate interventions or other life threatening complications 7. patient is unable to provide written informed consent and not capable to understand and comply to research protocol 8. patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule

Keywords: dementia moderate dementia neurocognitive impairment secretome hucsmc stem cells
resiliency training for patients with neurofibromatosis via videoconferencing with skype

Conditions: Neurofibromatosis; Neurofibromatosis I; Neurofibromatosis 2; Schwannomatosis

Summary: this study tests the efficacy of an 8-week, skype-based, group resiliency training intervention (the relaxation response resiliency program) for improving psychological stress in patients with neurofibromatosis. a control group will receive a general health education curriculum. the investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program. a substudy (unique protocol id: 2013p002605b) has been approved to test this study on a sub-population: patients with nf2 who are hard of hearing.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. can read and speak english at or above the 6th grade level 3. diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis exclusion criteria: 1. severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality) 2. recent (within past 3 months) change in antidepressant medication 3. use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months. 4. unable or unwilling to sign the informed consent documents 5. unable or unwilling to complete psychological assessments online via the redcap system. 6. unable or unwilling to participate in an intervention delivered via videoconferencing with skype.

Keywords: neurofibromatosis nf i nf 2 schwannomatosis stress management resiliency skype
fmri in spinal cord injury patient after rehabilitation

Conditions: Spinal Cord Injury

Summary: the purpose of this study was to evaluate the potential reorganization in the sensorimotor cortex in spinal cord injury (sci) patients after body weight supported treadmill training (bwstt) associated with conventional motor rehabilitation. the investigators hypothesized that training with weight bearing associated with conventional motor rehabilitation will be able to reorganize the brain.


Eligibility criteria:
inclusion criteria: * patients with asia c or d and the ability to cooperate with instructions of the motor task required. the motor task was to perform ankle plantar flexion and toe flexion and fingers and thumbs movement of the both sides; they also had to be able to fulfill the general conditions necessary for an mri exploration. exclusion criteria: * patients with uncontrollable spasticity-induced body movements were excluded from the study.
tamoxifen and clomiphene citrate in mild stimulation ivf

Conditions: Infertility

Summary: the purpose of this prospective cohort study is to compare ivf outcome between tamoxifen and clomiphene citrate in mild stimulation.

the reported prevalence of poor ovarian responders amongst patients undergoing ivf-et is 9%-24%, and morbidity must be higher nowadays. for these women, mild stimulation has been an important ovulation induction protocol. clomiphene citrate(cc) and tamoxifen(tmx) are commonly used in mild stimulation protocol. it's reported that cc has adverse effect on growth of endrometrium and results in thin endrometrium(≤7mm) which maybe affect pregnancy rate. however, tmx has estrogen-like effect on the endrometrium that may be helpful to increase endormetrial thickness. the reported results about comparing cc with tmx showed that they had similar ovulation rate. prospective study is necessary to confirm whether tmx is superior to cc on the ivf outcome.

Eligibility criteria:
inclusion criteria: 1. age between 37 and 42; 2. bmi≤23kg/m2; 3. ≤3 oocytes with a conventional stimulation protocol; 4. afc\<5 follicles or amh\<1.1 ng/ml on the day 1 to 5 of the menses; 5. cause of infertiity: tubal factor, male factor, diminished ovarian reserve. exclusion criteria: 1. endormetrial polyp, endormetrial cancer,intrauterine adhesions,uterine fibroids that affects uterine cavity 2. endometriosis, adenomyosis 3. the diameter of hydrosalpinx \>2cm

Keywords: tamoxifen clomiphene mild stimulation poor ovarian response clinical pregnancy rate
comparison of telemedicine to usual care for hcv management for methadone-maintained individuals

Conditions: Hepatitis C

Summary: to compare the effectiveness of a patient-centered, opiate agonist treatment (oat)-integrated telemedicine-based approach for management and delivery of hepatitis c virus (hcv) treatment to persons with substance use disorders (pwsud) versus usual care, which we anticipate in most cases will be referral to an offsite location for hcv management. the effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable hcv rna 12 weeks post-treatment cessation.

the study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite hcv management through telemedicine versus hcv management through usual care, referral to an offsite hepatitis specialist (referral). the arm assignment is at the cluster (clinic) level. after an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the usual care arm to the telemedicine arm. the process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. in addition, patients cured of hcv are followed for two years post-treatment cessation to assess for reinfection or relapse of hcv rna.

Eligibility criteria:
inclusion criteria: 1. hcv antibody detected 2. ability and willingness of subject or legal representative to provide written informed consent. 3. 18 years of age 4. a minimum of 12-month enrollment in the opiate agonist treatment program 5. likely to be adherent to the therapeutic regimen 6. covered by medical insurance exclusion criteria: 1. mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain. 2. \<18 years of age 3. \< 12 months enrolled in an opiate agonist treatment program. 4. non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. continuation in the study for the participant will be assessed on a case-by-case basis between the study pi and the site pi. 5. lack of medical insurance coverage 6. ineligibility for hcv treatment 7. active treatment for hcv at the time of the study enrollment